Enclomiphene

The EU EnCyzix (enclomifene) application, supported by 4 studies totaling 588 patients, was refused in 2018 (CHMP negative opinion 25 January 2018; formal refusal 6 April 2018). EMA noted that raising testosterone had not established the proposed clinical benefits (bone strength, weight gain, impotence, libido) and also identified a venous-thromboembolism safety concern. A biochemical increase alone is not proof of patient benefit.^[2]

Jurisdiction

European Union

Product

EnCyzix oral enclomifene

Indication

Proposed treatment of hypogonadotropic hypogonadism in overweight men (BMI >=25 kg/m2); authorization refused

Record date

2026-09-08

• Specific refused product and application; no global approval-status assertion.
• The application concerned overweight men with hypogonadotropic hypogonadism, a defined clinical population that is not the same as men using non-prescribed androgens. Nothing here describes enclomiphene's effects, safety or regulatory status in that different group.

A 2026 narrative review of clomiphene citrate's off-label use after anabolic-androgenic steroid cessation found that no standardized treatment exists and that clomiphene's clinical efficacy, safety and optimal monitoring strategy in that setting remain poorly defined. It reported that hormonal parameters often improve but symptomatic recovery varies, and that newer approaches, including the enclomiphene isomer, lack validation specifically in anabolic-steroid-induced hypogonadism populations.^[3]

• Narrative (non-systematic) review; abstract-checked only, full text paywalled.
• Describes the state of evidence and clinical practice patterns rather than reporting new trial data; does not itself establish or recommend any specific treatment approach.
• This finding documents an evidence gap; it is not a recommendation and should not be read as describing a validated or appropriate regimen.

A short phase II study in men with secondary hypogonadism found that oral enclomiphene raised testosterone and LH, while testosterone gel raised testosterone and suppressed LH. The study population explicitly excluded men with recent testosterone or anabolic-steroid use, so this did not establish recovery after anabolic-steroid use.^[1]

• Small short study; hormone measurements do not establish symptom benefit, pregnancy outcomes or post-AAS recovery.
• The study explicitly excluded men who had used testosterone in the prior 3 months, clomiphene in the prior year, or anabolic steroids; it characterizes idiopathic/age-related secondary hypogonadism, not steroid-induced suppression.
• Single-blind (not double-blind) design for the enclomiphene arms; open-label comparator; no placebo arm. No qualified clinical review.